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MEDICAL DEVICEREGULATIONSG lobal overview andguiding principlesWORLD HEALTH ORGANIZATIONGENEVADEPARTMENT OF BLOOD SAFETY AND CLINICAL TECHNOLOGYWORLD HEALTH ORGANIZATION1211 GENEVA 27 SWITZERLANDFax41 22 791 4836E-mail 4 154618 2 HEALTHCARE TECHNOLOGY LIFE CYCLEDe-commissioningMaintenanceTraining OperationTechnology assessmentEvaluationPlanningProcurementI nstallationCommissioningAssessment of needsResearchDevelopmentTestingManufactu reMarketingTransferDistributionACQUISITI ONUTILISATIONPROVISIONMEDICAL DEVICEREGULATIONSG lobal overview andguiding principlesWORLD HEALTH ORGANIZATIONGENEVAA cknowledgementsThis guide was prepared under the principal authorship of Dr Michael Cheng. It is basedon a similar publication issued by the Pan American Health Organization (PAHO) in1999 that reviewed the Canadian Medical Devices Regulatory comments and suggestions made by members of the Global Harmonization TaskForce and those of many other reviewers are gratefully Department of Blood Safety and Clinical Technology thanks the Governments ofItaly and Luxembourg for their continued support to its work on medical devices.

Medical device regulations : global overview and guiding principles. 1.Equipment and supplies – legislation 2.Equipment and supplies – standards 3.Policy making 4.Risk management 5.Quality control I.Title. ISBN 92 4 154618 2 (NLM Classification: WA 26)

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